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pre-operative abemaciclib
pre-operative abemaciclib is a Small molecule drug developed by National Cancer Institute (NCI). It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | pre-operative abemaciclib |
|---|---|
| Sponsor | National Cancer Institute (NCI) |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Testing the Addition of an Anti-Cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (5-Fluorouracil) for Metastatic, Refractory Colorectal Cancer (PHASE1)
- Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis (PHASE1)
- Molecular Surveillance In Early Breast Cancer Using The Tumor-Informed ctDNA Assay Myriad Genetics Precise MRD Test; A Prospective Observational Multicenter Study (The MRD Molecular Surveillance Study)
- Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer (PHASE1)
- PreOperative Endocrine Therapy for Individualised Care With Abemaciclib (PHASE3)
- RADIANT: Pre-op Radiation With Abemaciclib and Letrozole (PHASE1)
- Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma (PHASE1)
- Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- pre-operative abemaciclib CI brief — competitive landscape report
- pre-operative abemaciclib updates RSS · CI watch RSS
- National Cancer Institute (NCI) portfolio CI
Frequently asked questions about pre-operative abemaciclib
What is pre-operative abemaciclib?
Who makes pre-operative abemaciclib?
What development phase is pre-operative abemaciclib in?
Related
- Manufacturer: National Cancer Institute (NCI) — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing